Coupling devices and methods of using the same

ABSTRACT

In one embodiment, a medical device includes an elongate member, a first coupler, and a second coupler. The elongate member has a first end portion, a second end portion, and a side portion. The side portion of the elongate member has a first receiving portion and a second receiving portion. The first receiving portion is configured to receive a first support member. The second receiving portion is configured to receive a second support member. The first coupler is coupled to the elongate member and is configured to engage the first support member to help retain the first support member within the first receiving portion. The second coupler is coupled to the elongate member and is configured to engage the second support member to help retain the second support member within the second receiving portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This Patent Application is a continuation of U.S. patent applicationSer. No. 15/181,450, filed on Jun. 14, 2016 (published as U.S. PatentPublication No. 2016/0317192), which is a continuation of U.S. patentapplication Ser. No. 14/638,193, filed Mar. 4, 2015 (now U.S. Pat. No.9,387,012), which is a continuation of U.S. patent application Ser. No.13/352,711, filed Jan. 18, 2012, (now U.S. Pat. No. 8,998,956), which isa continuation-in-part application of U.S. patent application Ser. No.13/183,681, filed on Jul. 15, 2011 (now U.S. Pat. No. 9,649136), theentire contents of each of which are incorporated by reference herein intheir entireties for all purposes.

TECHNICAL FIELD

This disclosure relates generally to medical devices and moreparticularly to coupling devices configured to couple a first portion ofa medical support system to a second portion of a medical supportsystem.

BACKGROUND

A variety of medical devices and medical device systems are implantedwithin bodies of patients to provide support to portions of the bodiesof the patients. For example, some medical device systems are implantedand coupled to backbones or spines of patients and are configured toprovide support to the spinal bone structure of the patient. Somemedical device systems that are configured to provide support to thespinal bone structure of a patient include support members or rods thatextend between various portions of the medical device system. Forexample, the support members or rods may extend between portions of themedical device system that are coupled to adjacent vertebrae to providesupport to the spinal bone structure to promote healing of the bonestructures and/or otherwise maintain alignment and spacing of the spinalbone structures.

After implantation, however, the support members or rods of the medicaldevices or medical device systems may become weakened or break. It thenmay be necessary to perform an additional medical procedure to replaceor repair the broken or weakened support members or rods. Additionally,it may become necessary or desirable to couple various support membersor rods together after the implantation of such medical device systems.

Accordingly, there is a need for a coupling device that allows varioussupport members or rods to be coupled together. For example, there is aneed for a coupling device that is configured to allow broken orweakened rods to be coupled together. Additionally, there is a need fora coupling device that is configured to allow broken or weakened rods tobe coupled together without having to replace the support members orrods or perform a more difficult and time consuming procedure to bend ortorque the rods to force the support members or rods to conform to thespecific configuration of the coupling device. There is also a need fora coupling device that because of its size and profile avoids excessivetissue damage adjacent the surgical site.

SUMMARY

Systems, devices, and methods related to improved coupling mechanismsare provided. In some embodiments, an implantable system comprises abottom member having one or more slots for receiving one or more rodmembers; a top member attachable to the bottom member; and a set screwinsertable through both the top member and bottom member, whereinrotation of the set screw results in a secure locking of the system.

In other embodiments, an implantable system comprises a bottom memberhaving a pair of slots for receiving two rod members; a top memberattachable to the bottom, whereby in a first open orientation, the topmember does not obscure openings of the pair of slots, while in a secondclosed orientation, the top member does obscure openings of the pair ofslots; and a set screw insertable through both the top member and bottommember.

In other embodiments, an implantable system comprises a bottom memberhaving one or more slots for receiving rod members; a top memberattachable to the bottom member, the top member including an upperportion and a lower portion insertable into an aperture formed in thebottom member; and a set screw insertable through both the top memberand bottom member.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 are perspective views of a medical device according to anembodiment of the invention.

FIG. 3 is a perspective view of a portion of the medical device of FIGS.1 and 2.

FIG. 4 is a perspective view of a medical device according to anembodiment of the invention.

FIG. 5 is a perspective view of a coupler of a medical device accordingto an embodiment of the invention.

FIG. 6 is a perspective view of a ring of the coupler of FIG. 5.

FIG. 7 is an end view of the medical device of FIG. 5.

FIG. 8 is a cross-sectional view of the medical device of FIG. 5 takenalong line A-A of FIG. 9.

FIG. 9 is a top view of the medical device of FIG. 5.

FIG. 10 is a perspective view of a medical device according to anembodiment of the invention.

FIG. 11 is an end view of the medical device of FIG. 10.

FIG. 12 is a top view of the medical device of FIG. 10.

FIG. 13 is a perspective view of the medical device of FIG. 10 coupledto a medical device system.

FIG. 14 is a perspective view of a medical device coupled to a medicaldevice system.

FIGS. 15 and 16 are perspective views of a medical device according toan embodiment of the invention.

FIG. 17 is a perspective view of the medical device of FIGS. 15 and 16coupled to a medical device system.

FIG. 18 is a perspective view of a medical device according to anembodiment of the invention.

FIG. 19 is a perspective view of a medical device according to anembodiment of the invention.

FIG. 20 is a top view of the medical device of FIG. 19 coupled to amedical device system.

FIG. 21 is a perspective view of a medical device according to anembodiment of the invention.

FIG. 22 is a perspective view of a medical device coupled to a medicaldevice system.

FIGS. 23-26 are perspective views of medical devices according toembodiments of the invention.

FIGS. 27 and 28 are side views of medical devices according toembodiments of the invention.

FIGS. 29 and 30 are perspective views of a medical device according toan embodiment of the invention.

FIGS. 31 and 32 are perspective views of a medical device according toan embodiment of the invention.

FIGS. 33 and 34 are side views of medical devices according toembodiments of the invention.

FIG. 35 is an exploded view of a staple stabilization system accordingto some embodiments of the present application.

FIG. 36 is a side view of a staple stabilization system according tosome embodiments of the present application.

FIG. 37 is a top perspective view of a staple stabilization systemhaving rod members with a top member in an open position according tosome embodiments of the present application.

FIG. 38 is a top perspective view of a staple stabilization systemhaving rod members with a top member in a closed position according tosome embodiments of the present application.

FIG. 39 is a top perspective view of a bottom member of a staplestabilization system according to some embodiments of the presentapplication.

FIG. 40 is a bottom view of a staple stabilization system according tosome embodiments of the present application.

FIG. 41 is a top perspective view of an alternative staplestabilizations system according to some embodiments of the presentapplication.

DETAILED DESCRIPTION

The devices and methods described herein are generally directed toprocedures for coupling portions of bodily implants together within abody of a patient. In some embodiments, the implants are configured toprovide support to a portion of the body of the patient. For example, insome embodiments, the devices and methods described herein areconfigured to provide support to a spine or back of a patient. In otherembodiments, other portions of the body of the patient are supported bythe devices.

FIGS. 1 and 2 are perspective views of an apparatus or medical device100 according to an embodiment of the invention. FIG. 3 is a perspectiveview of a portion of the apparatus or medical device 100. The apparatusor medical device 100 is configured to be coupled to portions of amedical device system to provide support to the medical device system.In the illustrated embodiment, the medical device 100 is configured tobe coupled to a first support member SM and a second support member (notillustrated) of a medical device system. For example, in the illustratedembodiment, the medical device 100 is configured to be coupled tosupport members or rods of a spinal implant.

The apparatus or medical device 100 includes an elongate member 110,couplers 120, 130, 140, and 150 of a first type, and couplers 160 and170 of a second type. The elongate member 110 includes a first endportion 112, a second end portion 114, and a side portion 116. The firstend portion 112 is disposed opposite the second end portion 114. Theside portion 116 extends from the first end portion 112 to the secondend portion 114.

The side portion 116 defines a first receiving portion 117 and a secondreceiving portion 118. The first receiving portion 117 is configured toreceive and house a first support member SM or rod of a medical devicesystem (such as a spinal implant system). In the illustrated embodiment,first receiving portion 117 is configured to receive and house a portionof the first support member SM (and a portion of the first supportmember SM extends from the elongate member 100). The second receivingportion 118 is configured to receive and house a second support memberof the medical device system or a portion of the second support memberof the medical device system.

In the illustrated embodiment, the first receiving portion 117 and thesecond receiving portion 118 each include a cavity and an opening, suchas an elongate opening that is in communication with the cavity. Thefirst support member SM may be inserted into or otherwise coupled to theelongate member 110 by moving the first support member SM through theopening and into the cavity of the first receiving portion 117 of theside portion 116. Similarly, in the illustrated embodiment, the secondsupport member SM may be inserted into or otherwise coupled to theelongate member 110 by moving the second support member through theopening and into the cavity of the second receiving portion 118 of theside portion 116.

In some embodiments, the first support member SM is coupled to a firstportion of the medical device system and the second support member iscoupled to a second portion of the medical device system. The apparatus100 may be used to couple the first support member to the second supportmember to operatively couple the first portion of the medical devicesystem to the second portion of the medical device system. In someembodiments, the first portion of the medical device system is a bonescrew that is coupled to a first vertebrae and the second portion of themedical device system is a bone screw that is coupled to a secondvertebrae. In some embodiments, the first support member SM and thesecond support member may be portions of a support member that brokeinto the first support member SM and the second support member. In suchembodiments, the apparatus 100 or coupling device may be used torecouple the first support member SM to the second support member torepair the broken support member.

In some embodiments, the first receiving portion 117 and the secondreceiving portion 118 each include a sloped or ramped surface. Thesloped or ramped surfaces are configured to help retain the supportmembers within the receiving portions 117 and 118. For example, in someembodiments, the sloped or ramped surfaces are configured to help retainthe support members within the receiving portions 117 and 118 via africtional fit. In some embodiments, the lower surfaces 115 and 119include sloped or ramped surfaces to help retain the support memberswithin the receiving portions 117 and 118.

In the illustrated embodiment, the elongate member 110 is generallytubular in shape and has a relatively low profile. In other words, thecross-sectional sectional shape of the elongate member 110 (taken alonga line generally perpendicular to the longitudinal axis LA of theelongate member) is generally circular. The diameter of the elongatemember is relatively small to allow the apparatus 100 to avoidunnecessary disruption of the tissue surrounding the surgical site.Although the cross-sectional shape of the elongate member 110 isgenerally circular in the illustrated embodiment, in other embodiments,the elongate member has a different cross-sectional shape. For example,in some embodiments, the elongate member has an oval, rectangle, or anyother cross-sectional shape.

In some embodiments, the first receiving portion 117 and the secondreceiving portion 118 are configured to receive and house supportmembers of the same sizes, dimensions, or shapes. For example, in someembodiments, the first receiving portion 117 and the second receivingportion 118 are of the same size or include openings and cavities of thesame size. In other embodiments, the first receiving portion 117 isconfigured to receive and house a support member of a first size,dimension, or shape and the second receiving portion 118 is configuredto receive and house a support member of a second size, dimension, orshape different than the first size, dimension, or shape. For example,in some embodiments, the first receiving portion 117 is of a first width(has an opening or a cavity of a first width) and the second receivingportion 118 has a second width (has an opening or a cavity of a secondwidth) greater than the first width.

Couplers 120, 130, 140, and 150 are of similar construction andfunction. Accordingly, only the coupler 120 will be described in detail.The coupler 120 is coupled to the elongate member 110. The coupler 120is configured to move from a first position to a second position toengage a support member that is disposed within the first receivingportion 117 to help retain the support member within the first receivingportion 117. In other words, the coupler 120 is configured to at leastcontribute to the retention (for example, during normal bodilyconditions) of the support member within the first receiving portion117. In some embodiments, the coupler 120 is configured to engage thesupport member such that the frictional fit of the support member withinthe first receiving portion 117 is increased. In other words, thecoupler 120 is configured to apply a pressure to the support member tohelp retain the support member within the first receiving portion 117.

In other embodiments, the coupler 120 is configured to move from a firstposition while the support member is being inserted into the receivingportion to a second position after the support member is disposed withinthe receiving portion to provide a barrier (i.e., to partially close theopening) to help prevent the removal of the support member from thefirst receiving portion 117.

In the illustrated embodiment, coupler 120 includes a set screw. The setscrew of the coupler 120 can be rotated with respect to the elongatemember 110 to move the set screw of the coupler 120 from a firstposition with respect to the elongate member 110 to a second positionwith respect to the elongate member 110. When the set screw of thecoupler 120 is in its second position a portion of the set screw extendsinto the first receiving portion 117 and is configured to contact orengage the support member SM disposed within the first receiving portion117 (as best illustrated in FIG. 1) to help retain the support memberwithin the first receiving portion 117.

Couplers 120, 130, 140, and 150 are longitudinally offset from eachother. In other words, the couplers 120, 130, 140, and 150 are offsetfrom each other along an axis parallel to the longitudinal axis LA ofthe support member 110. Couplers 120 and 130 are disposed such that theyare configured to contact or engage the support member SM that isdisposed within the first receiving portion 117. Couplers 140 and 150are disposed such that they are configured to contact or engage asupport member that is disposed within the second receiving portion 118.

Couplers 160 and 170 are structurally and functionally similar.Accordingly, only coupler 160 will be discussed in detail. Coupler 160is coupled to the elongate member 110 and is configured to engage thefirst support member SM once the support member SM is disposed withinthe first receiving portion 117. Specifically, the coupler 160 isconfigured to move from a first position to a second position to engagea support member that is disposed within the first receiving portion 117to help retain the support member within the first receiving portion117. In some embodiments, the coupler 160 is configured to engage thesupport member such that the frictional fit of the support member withinthe first receiving portion 117 is increased. In other words, thecoupler 160 is configured to apply a pressure to the support member tohelp retain the support member within the first receiving portion 117.

Coupler 160 is configured to be disposed at different locations along anaxis parallel to the longitudinal axis LA of the elongate member 110. Inthe illustrated embodiment, coupler 160 is slidably coupled within aslot 109 defined by the elongate member 110. In other embodiments,coupler 160 is configured to be removably coupled to the elongate member110 at different locations along an axis parallel to the longitudinalaxis LA of the elongate member 110. The ability of coupler 160 toslidably move within slot 109 allows coupler 160 to accommodate avariety of differently dimensioned support members as well asaccommodate a variety of differently positioned support members.

In the illustrated embodiment, coupler 160 includes a screw portion anda cam member. Specifically, the coupler 160 includes a cam member thatis configured to extend into the first receiving portion 117 (such asthe cavity) to and engage or contact the support member to help retainthe support member within the first receiving portion 117. The cammember may be moved into engagement and out of engagement with thesupport member by rotating the screw portion with respect to theelongate member 110. Accordingly, the support member may be insertedinto the receiving portion 117 and appropriately positioned while thecam member does not extend into the receiving portion (or is in alocation outside of engagement with the support member). Once thesupport member is inserted into the receiving portion, the screw membermay be rotated with respect to the elongate member to cause the cammember to engage the support member and help retain the support memberwithin the first receiving portion 117.

In the illustrated embodiment, coupler 170 is slidably disposed withinslot or groove 108 that is defined by the elongate member 110. Slot 109and slot 108 are disposed within the same plane. More specifically, slot109 and slot 108 are offset along an axis that extends parallel to thelongitudinal axis LA of the elongate member 110.

In some embodiments, the elongate member defines a single slot in whichboth coupler 170 and coupler 160 move or slide within.

In the illustrated embodiment, coupler 170 and coupler 160 are radiallyoffset from the couplers 120, 130, 140, and 150.

The components of the medical device 100 may be made or formed of anybiocompatible material. For example, the components of the medial device100 may be formed of a biocompatible plastic or polymer or abiocompatible metal material.

In use, the medical device or coupler 100 may be used to couple variousportions of a medical device system together. In one embodiment, themedical device 100 may be used to couple a first support member of aspinal implant to a second portion of the spinal implant.

The medical device 100 may be moved with respect to the first portion ofthe medical device system (such as a support member of the medicaldevice system) to insert the first portion of the medical device systeminto the first receiving portion 117 of the medical device 100. As thereceiving portion 117 is disposed on a side portion 116 of the elongatemember 110, the first portion of the medical device may be movedlaterally into the first receiving portion 117. In other words, anend-most portion of the first portion of the medical device system doesnot need to be inserted into the receiving portion first. Rather, thereceiving portion 117 may laterally receive the first portion of themedical device system.

Coupler 120 and 130 may then be rotated to help retain the first portionof the medical device system within the first receiving portion 117.Coupler 160 may then be moved or slid along the elongate member 110 to alocation appropriate to engage the first portion of the medical devicesystem. Coupler 160 may then be rotated with respect to the elongatemember 110 to cause a cam portion of the coupler 160 to engage the firstportion of the medical device system to help retain the first portion ofthe medical device system within the first receiving portion 117.

The above process may be used to couple the medical device 100 to asecond portion of the medical device system (such as a second supportmember of a spinal implant). Specifically, the above process may be usedto couple the second portion of the medical device system within thesecond receiving portion 118.

FIGS. 4-9 illustrate another embodiment of an apparatus or medicaldevice 200. The apparatus or medical device 200 includes an elongatemember 210, couplers 220 and 230, and couplers 240 and 250. In theillustrated embodiment, couplers 220 and 230 are of a first type andcouplers 240 and 250 are of a second type different than the first type.

The elongate member 210 includes a first end portion 212, a second endportion 214, and a side portion 216. The first end portion 212 isdisposed opposite the second end portion 214. The side portion 216extends from the first end portion 212 to the second end portion 214.

The side portion 216 defines a first receiving portion 217 and a secondreceiving portion 218. The first receiving portion 217 is configured toreceive and house a first support member or rod of a medical devicesystem (such as a spinal implant system). In the illustrated embodiment,first receiving portion 217 is configured to receive and house a portionof the first support member. The second receiving portion 218 isconfigured to receive and house a second support member of the medicaldevice system or a portion of the second support member of the medicaldevice system.

In the illustrated embodiment, the first receiving portion 217 and thesecond receiving portion 218 each include a cavity and an opening, suchas an elongate opening that is in communication with the cavity. Thefirst support member may be inserted into or otherwise coupled to theelongate member 210 by moving the first support member through theopening and into the cavity of the first receiving portion 217 of theside portion 216. Similarly, in the illustrated embodiment, the secondsupport member may be inserted into or otherwise coupled to the elongatemember 210 by moving the second support member through the opening andinto the cavity of the second receiving portion 218 of the side portion216.

Couplers 220 and 230 are of similar construction and function.Accordingly, only the coupler 220 will be described in detail. Thecoupler 220 is coupled to the elongate member 210. The coupler 220 isconfigured to move from a first position to a second position to engagea support member that is disposed within the first receiving portion 217to help retain the support member within the first receiving portion217. For example, as illustrated in FIG. 7, the coupler 220 includes acontact portion 222 that is configured to extend into the firstreceiving portion 217 and engage a support member disposed within thefirst receiving portion 217. In some embodiments, the coupler 220 isconfigured to engage the support member such that the frictional fit ofthe support member within the first receiving portion 217 is increased.In other words, the coupler 220 is configured to apply a pressure to thesupport member to help retain the support member within the firstreceiving portion 217.

In the illustrated embodiment, coupler 220 includes a set screw. The setscrew of the coupler 220 can be rotated with respect to the elongatemember 210 to move the set screw of the coupler 220 from its firstposition with respect to the elongate member 210 to its second positionwith respect to the elongate member 210. As best illustrated in FIG. 7,when the set screw of the coupler 220 is in its second position aportion (such as portion 222) of the set screw extends into the firstreceiving portion 217 and is configured to contact or engage the supportmember disposed within the first receiving portion 217 to help retainthe support member within the first receiving portion 217.

Couplers 220 and 230 are laterally offset from each other along an axisparallel to a longitudinal axis of the support member 210. Coupler 220is disposed such that it is configured to contact or engage a supportmember that is disposed within the first receiving portion 217. Coupler230 is disposed such that it is configured to contact or engage asupport member that is disposed within the second receiving portion 218.

Couplers 240 and 250 are structurally and functionally similar.Accordingly, only coupler 240 will be discussed in detail. Coupler 240is coupled to the elongate member 210 and is configured to engage thefirst support member once the support member is disposed within thefirst receiving portion 217. Specifically, the coupler 240 is configuredto move from a first position to a second position to engage a supportmember that is disposed within the first receiving portion 217 to helpretain the support member within the first receiving portion 217. Insome embodiments, the coupler 240 is configured to engage the supportmember such that the frictional fit of the support member within thefirst receiving portion 217 is increased. In other words, the coupler240 is configured to apply a pressure to the support member to helpretain the support member within the first receiving portion 217.

Coupler 240 is configured to be disposed at different locations along anaxis parallel to the longitudinal axis of the elongate member 210. Inthe illustrated embodiment, coupler 240 is slidably coupled within aslot 209 defined by the elongate member 210. In other embodiments,coupler 240 is configured to be removably coupled to the elongate member210 at different locations along an axis parallel to the longitudinalaxis of the elongate member 210.

As best illustrated in FIGS. 4, 7, and 8, the medical device 200includes retention rods 280 and 290 that extend through at least aportion of the elongate member 210. The retention rods 280 and 290extend along the slot 209 defined by the elongate member 210. Theretention rods 280 and 290 are configured to engage the couplers 240 and250 to help retain the couplers 240 and 250 within the slot 209. Forexample (as best illustrated in FIG. 8), in some embodiments, thecouplers 240 and 250 are configured to slide along the retention rods280 and 290.

In some embodiments, to slidably dispose the couplers 240 and 250 withinthe slot 209, the couplers 240 and 250 may be placed within slot 209 andthen the retention rods 280 and 290 may be slid into the elongate member210. The retention rods 280 and 290 may be slid into the elongate member210 such that they engage a portion of the couplers 240 and 250 toslidably retain the couplers on the retention rods 280 and 290 andwithin the slot 209.

In other embodiments, the couplers 240 and 250 may include a retentionring (such as retention ring 242 as illustrated in FIG. 6). The couplers240 and 250 may be inserted into the slot 209 and the retention ringsmay be snapped or coupled to the couplers 240 and 250. The retentionrings may then be disposed within slots or grooves defined by theelongate member 210 to slidably couple the couplers 240 and 250 withinthe slot 209.

In the illustrated embodiment, coupler 240 includes a screw portion 244and a cam member 246. Specifically, the coupler 240 includes a cammember 246 that is configured to extend into the first receiving portion217 and engage or contact the support member to help retain the supportmember within the first receiving portion 217. The cam member 246 may bemoved into engagement and out of engagement with the support member byrotating the screw portion 244 with respect to the elongate member 210.Accordingly, the support member may be inserted into the receivingportion 217 while the cam member 246 does not extend into the receivingportion 217 (or is in a location outside of engagement with the supportmember). Once the support member is inserted into the receiving portion217, the screw member 244 may be rotated with respect to the elongatemember 210 to cause the cam member 246 to engage the support member andhelp retain the support member within the first receiving portion 217.

In the illustrated embodiment, coupler 240 and coupler 250 arelongitudinally offset from the couplers 220 and 230.

FIGS. 10-12 illustrate another embodiment of an apparatus or medicaldevice 300. The apparatus or medical device 300 is configured to coupletwo portions of a medical device system together. Specifically, themedical device 300 is configured to couple various portions of a brokensupport member or rod of a spinal implant. Such breaks of supportmembers or rods may occur near the bone screws or bone anchors. Themedical device 300 is configured to be coupled to the broken supportmembers or rods at locations proximate the bone screws or bone anchors.In one example, medical device 300 may couple broken rods in an end toend or co axial orientation.

The medical device 300 includes an elongate member 310 and couplers 320,330, 340, and 350. The elongate member 310 includes a first end portion312, a second end portion 314, and a side portion 316. The side portion316 defines a first receiving portion 317 and a second receiving portion318.

The receiving portions 317 and 318 are configured to receive and houseportions of a medical device system (such as support members or rods ofa spinal implant). The couplers 320, 330, 340, and 350 are configured tomove from first positions to second positions. In their first positions,the couplers 320, 330, 340, and 350 are configured to allow the portionsof the medical device system to be inserted into the receiving portions317 and 318. At their second positions, the couplers 320, 330, 340, and350 are configured to contact or engage the support members or rods tohelp retain the support members within the receiving portions 317 and318.

In the illustrated embodiment, the elongate member 310 includes a narrowor thin portion 313. In some embodiments, the narrow or thin portion 313may be bent or curved to facilitate the coupling of the medical device300 to various portions of a medical device system.

FIG. 13 illustrates the medical device 300 coupled to portions of amedical device system MDS. The medical device system MDS includes afirst support member SM1, a second support member SM2, a first boneanchor BA1, and a second bone anchor BA2. The medical device 300 iscoupled to the first support member SM1 and to the second support memberSM2. In the illustrated embodiment, the elongate member 310 defines anopen portion 311. As best illustrated in FIG. 13, the open portion 311of the elongate member 310 is configured to receive a bone screw or abone anchor when the medical device is coupled to first support memberSM1 and the second support member SM2 of the medical device system MDS.

As illustrated in FIG. 14, in another embodiment, a medical device 400includes an elongated open portion 411. The open portion is configuredto receive more than one bone screw or bone anchor.

FIGS. 15 and 16 illustrate an apparatus or medical device 500. Theapparatus or medical device 500 may be used to couple various portionsof a medical device system together. For example, the medical device 500may be used to couple a first support member or rod and a second supportmember or rod of a spinal implant together. In some embodiments, themedical device 500 may be used to couple portions of a spinal implantthat is currently in place within the body of a patient. In someembodiments, the use of the medical device 500 may provide a lessdisruptive surgery, decrease the time of surgery, or minimize thedissection area.

The medical device 500 includes an elongate member 510, a first coupler512, and a second coupler 514. The elongate member 510 includes a firstend portion 512, a second end portion 514 opposite the first end portion512, a first side portion 516, and a second side portion 515 oppositethe first side portion 516. In the illustrated embodiment, the firstside portion 516 and the second side portion 515 each extend from thefirst end portion 512 to the second end portion 514.

The first side portion 516 defines a first receiving portion 517 and thesecond side portion 515 defines a second receiving portion 518. Thereceiving portions are configured to receive and house support membersor rods of a spinal implant system. In the illustrated embodiment, thefirst receiving portion 517 is configured to receive a support member ofa first size and the second receiving portion 518 is configured toreceive a support member of a second size smaller than the first size.Thus, the medical device 500 may be used to couple a support member orrod of a first size to a support member or rod of a second, differentsize.

The coupling members 520 and 530 are screw members that may be placed ina first position (as illustrated in FIG. 15) to allow the supportmembers to be placed or inserted into the receiving portions 517 and518. The coupling members 520 and 530 may be placed in a second position(as illustrated in FIG. 16) to contact or engage the support membersdisposed in the receiving portions 517 and 518 to help retain thesupport members within the receiving portions 517 and 518.

FIG. 17 illustrates the medical device 500 coupled to a first supportmember SM3 and a second support member SM4. The first support member SM3is disposed within the first receiving portion 517 and the secondsupport member SM4 is disposed within the second receiving portion 518.The first support member SM3 is larger in diameter than the secondsupport member SM4. FIG. 17 illustrates that the support members SM3 andSM4 are received in a substantially parallel orientation.

FIG. 18 is a perspective view of an embodiment of a medical device 600.The medical device 600 includes an elongate member 610, a first coupler620, and a second coupler 630. The elongate member 610 defines a firstreceiving portion 617 and a second receiving portion 618. The firstreceiving portion 617 has a C-shaped and may laterally receive a supportmember of a spinal implant. In other words, the first receiving portion617 may receive a support member that is disposed at the side of medicaldevice 600. The second receiving portion 618 is a lumen that includes afirst end portion and opening and a second end portion and opening. Thesecond receiving portion 618 is configured to receive a support memberfrom an end portion of the elongate member 610 (through an end of thelumen).

FIG. 19 is a perspective view of an embodiment of a medical device 700.The medical device 700 includes an elongate member 710, a first coupler720 and a second coupler 730. The elongate member 710 defines tworeceiving portions 716 and 717 that are lumens that are configured toreceive support members from an end portion of the medical device 700.FIG. 20 illustrates the medial device 700 coupled to a first supportmember SM5 and a second support member SM6. The first support member SM5is larger in diameter than the second support member SM6.

FIG. 21 is a perspective view of an embodiment of a medical device 800.The medical device 800 includes an elongate member 810, a first coupler820 and a second coupler 830. The elongate member 810 defines tworeceiving portions 817 and 818. The receiving portions 817 and 818define lumens that are configured to receive support members from an endportion of the medical device 800.

FIG. 22 is a perspective view of medical devices 900 and 1000 coupled toa support member SM7. The medical devices 900 and 1000 are configured tomove along the support member SM7. For example, the medical devices 900and 1000 may be configured to slide along the support member SM7. Onceplaced in the correct location along the support member SM7, thecouplers 920 and 1020 of the medical devices 900 and 1000, respectively,may be moved or screwed down to fixedly couple the medical devices 900and 1000 to the support member SM7.

In some embodiments, the support member SM7 is prevented from rotatingwithin the receiving portions of the medical devices 900 and 1000. Forexample, the receiving portions may have a shape, an engagement member,or other feature that helps prevent the support member SM7 from rotatingwithin the receiving portions with respect to the medical devices 900and 1000.

In the illustrated embodiment, the medical devices 900 and 1000 areconfigured to be coupled to a second support member. As illustrated,medical device 900 is coupled to a second support member SM8.

In the illustrated embodiment, a medical device 1100 is fixedly coupledto one end portion of the support member SM7. In other words, themedical device 1100 is not configured to move along the support memberSM7.

FIGS. 23-26 are perspective views of various embodiments of medicaldevices 1200, 1300, 1400, and 1500. The medical devices 1200, 1300,1400, and 1500 are configured to couple an end portion of a supportmember (such as a rod of a spinal implant) to an end portion of anothersupport member. The medical devices 1200, 1300, 1400, and 1500 may beconfigured to be coupled to support members of different sizes.

As illustrated in FIG. 23, the medical device 1200 includes an elongatemember 1210, a first coupler 1220, and a second coupler 1230. Theelongate member 1210 defines a first receiving portion 1217 configuredto receive a first support member. The elongate member 1210 also definesa second receiving portion (not illustrated) configured to receive asecond support member. The elongate member 1210 defines an opening or awindow 1203 that is configured allow a user to view the support members(or a portion of the support members) once the support members aredisposed within the first receiving portion 1217 and second receivingportion. In the illustrated embodiment, the opening or window 1203 isdisposed on a top surface of the elongate member 1210. Specifically, theopening or window 1203 is disposed between the first coupler 1220 andthe second coupler 1230 and is longitudinally offset from the firstcoupler 1220 and the second coupler 1230.

As illustrated in FIG. 24, the medical device 1300 includes an elongatemember 1310, a first coupler 1320, and a second coupler 1330. Theelongate member 1310 defines a first receiving portion 1317 configuredto receive a first support member. The elongate member 1310 also definesa second receiving portion configured to receive a second supportmember. The elongate member 1310 defines an opening or a window 1303that is configured allow a user to view the support members (or aportion of the support members) once the support members are disposedwithin the first receiving portion 1317 and second receiving portion. Inthe illustrated embodiment, the opening or window 1303 is disposed on atop surface of the elongate member 1310.

As illustrated in FIG. 25, the medical device 1400 includes an elongatemember 1410, a first coupler 1420, and a second coupler 1430. Thesupport member 1410 defines a first receiving portion 1417 configured toreceive a first elongate member. The elongate member 1410 also defines asecond receiving portion (not illustrated) configured to receive asecond support member. The elongate member 1410 defines an opening or awindow 1403 that is configured allow a user to view the support members(or a portion of the support members) once the support members aredisposed within the first receiving portion 1417 and second receivingportion. In the illustrated embodiment, the opening or window 1403 isdisposed on a side surface of the elongate member 1410 and is radiallyoffset from the first coupler 1417 and the second coupler 1430.

As illustrated in FIG. 26, the medical device 1500 includes an elongatemember 1510, a first coupler 1520, and a second coupler 1530. Thesupport member 1510 defines a first receiving portion 1517 configured toreceive a first elongate member. The elongate member 1510 also defines asecond receiving portion (not illustrated) configured to receive asecond support member. The elongate member 1510 defines an opening or awindow 1503 that is configured allow a user to view the support members(or a portion of the support members) once the support members aredisposed within the first receiving portion 1517 and second receivingportion. In the illustrated embodiment, the opening or window 1503 isdisposed on a side surface of the elongate member 1510.

FIGS. 27 and 28 illustrate connectors that 1600 and 1700 are configuredto connect a rod or support member to a support member or rod of amedical device system (such as a spinal implant). In some embodiments,the connectors 1600 and 1700 allow the support members to be coupled inan offset manner, decrease the time of surgery, and provide lessdisruptive options for surgery. Additionally, in some embodiments, theconnectors 1600 and 1700 provide options for accommodating varyingpatient anatomy and may help lower morbidity rate in surgeries.

As illustrated in FIG. 27, connector 1600 includes a connector portion1610 coupled to a support portion 1620. In some embodiments, theconnector portion 1610 is integral or unitarily formed with the supportportion 1620 which may be coupled to another component of a medicaldevice system such as a bone screw. The connector portion 1610 defines alumen 1612 that is configured to receive a support member of a medicaldevice system. The connector 1600 also includes a set screw 1630 that isconfigured to engage a support member that is disposed within the lumen1612 to help retain the support member within the lumen 1612.

As illustrated in FIG. 28, connector 1700 includes a connector portion1710 that defines a cavity 1712 and an opening 1714 that communicateswith the cavity 1712. Accordingly, a support member of a medical devicesystem may be inserted into the cavity 1712 via the opening 1714.

FIGS. 29 and 30 illustrate a medical device 1800 and FIGS. 31 and 32illustrate a medical device 1900. The medical devices 1800 and 1900 areconfigured to be implanted into a body of a patient and provide supportto a body or a portion of the body of the patient. For example, themedical devices 1800 and 1900 may be coupled to a spine of a patient toprovide support to the spine of the patient or may be coupled to anexisting spinal implant.

In some embodiments, the medical devices 1800 and 1900 includeconnection portions 1810 and 1910 and support rod portions 1820 and 1920that are integral or unitarily formed. In some embodiments, integral orunitary construction provides a stronger medical device, reduces thenumber of fixation points of an implant, and reduces construction time.Rod portions 1820 and 1920 are configured and dimensioned to mate withother medical device systems or components such as device connectors orbone screws.

In some embodiments, the medical devices are formed of a stiff materialsuch as a metal material. In some embodiments, the medical devices 1800and 1900 are configured to align with the anatomical location of L5pedicles. In such embodiments, the screws may be more easily placed. Inother words, the devices 1800 and 1900 may not need to be bent in situto align the screws.

In some embodiments, the medical devices 1800 and 1900 provide aplatform for L5 reduction.

As illustrated in FIGS. 29 and 30, medical device 1800 includes aconnection portion 1810 and a rod portion 1820. The connection portion1810 defines openings 1812 and 1814. The openings 1812 and 1814 areconfigured to receive bone anchors or bone screws. As illustrated inFIG. 33, the bone anchors or bone screws may be retained within theopenings 1812 and 1814 via a pair of couplers 1830 and 1840. In someembodiments, the couplers 1830 and 1840 are screws that are configuredto engage the bone screws or bone anchors to help retain such boneanchors or bone screws within the openings 1812 and 1814.

As illustrated in FIG. 34, in another embodiment, a cam member 1850 maybe used to engage the bone anchors or bone screws to help retain thebone anchors or bone screws within the openings 1812 and 1814. Forexample, in some embodiments, the cam member 1850 maybe rotated from aposition of disengagement (to allow the bone screws or bone anchors tobe inserted into the openings 1812 and 1814) to a position of engagement(to help retain the bone screws or bone anchors within the openings 1812and 1814).

As illustrated in FIGS. 31 and 32, the medical device 1900 includes acoupling portion 1910 and a rod portion 1920.

As best illustrated in FIG. 29, the rod portion 1820 curves to the rightof the coupling portion 1810. As best illustrated in FIG. 31, the rodportion 1920 curves to the left of the coupling portion 1820.

Additional Embodiments

Additional embodiments of coupling systems and devices are nowdescribed. In particular, FIGS. 35-41 show different views of a novelstaple stabilization system and individual components for attachment toone or more vertebral members. The staple stabilization systemadvantageously is of low profile, thereby helping to reduce the risk oftissue abrasion and damage in and around a surgical site.

FIG. 35 illustrates an exploded view of a staple stabilization systemaccording to some embodiments of the present application. The staplestabilization system 2000 includes three low-profile components: a topmember 1921 in the form of a top plate, a bottom member 1930 in the formof a bottom plate, and a set screw 2010.

The staple stabilization system 2000 is configured to receive and secureone or more rod members (as shown in FIGS. 37 and 38) for stabilizationof the spine. When the system is in an “open” configuration, the staplestabilization system 2000 can receive rod members 1950, 1952 that restwithin slots 1931, 1932 formed on the bottom member 1930, as shown inFIG. 37. In the open configuration, the top member 1921 is oriented suchthat its walls do not obstruct the openings of the slots 1931, 1932.Once the rod members 1950, 1950 are deposited in the slots 1931, 1932,the top member 1921 can be rotated and actuated into a “closed”position, whereby the rod members 1950, 1952 are securely held withinthe system, as shown in FIG. 38. To further secure the rod members 1950,1952 within the system, the set screw 1912 can be rotated and tightened.Further details regarding the securing of the rod members 1950, 1950 tothe system 2000 are discussed below.

As shown in FIG. 35, the bottom member 1930 is in the form of a platehaving a pair of slots 1931, 1932 formed therein. The slots 1931 and1932 are configured to receive rod members, as discussed above. Theslots 1931 and 1932 include openings 1938 and 1939 (shown in FIGS. 39and 40) that extend to a bottom surface of the bottom member 1930. Theopenings 1938 and 1939 are configured to receive one or more bonescrews, such as bone screw 1960 in FIGS. 37 and 38, for securing thesystem to a vertebral body.

The bottom member 1930 further includes a middle opening 1933 in betweenthe slots 1931 and 1932 that extends from a top surface to a bottomsurface of the bottom member 1930. The middle opening 1933 of the bottommember 1930 is configured to receive a portion of the top member 1921therein. The middle opening 1933 of the bottom member 1930 is alsoconfigured to have threads 1941 (as shown in FIG. 39) that can mate withthreads of a set screw 2010 to secure the rod members within the system.

The bottom member 1930 further includes one or more protruding membersor prongs 1935 and 1936 that can extend from a bottom surface of thebottom member 1930. In some embodiments, the protruding members 1935 and1936 have pointed tips that can advantageously engage a surface of avertebral body prior to inserting additional bone screws through thesystem. This way, the protruding members 1935, 1936 help to stabilizethe system against a vertebral member even before the staple system issecured to the vertebral member.

As shown in FIG. 35, the top member 1921 is in the form of a platemember having an upper portion 2020 and a lower portion 1924. The lowerportion 1924 is configured to be received within the opening 1933 of thebottom member 1930. In addition, an opening 1922 (shown in FIG. 35) forreceiving a set screw 2010 is formed in the top member 1921 from a topsurface to a bottom surface of the top member. While in someembodiments, the opening 1922 is substantially circular, in otherembodiments, the opening 1922 is non-circular and can receive a setscrew having a variety of different shapes.

As shown in FIG. 35, the set screw 1912 includes an upper screw portion2012 and a lower screw portion 1913. The upper screw portion 2012 cancomprise a cylindrical body. In some embodiments, the upper screwportion 2012 includes one or more threads that can mate with a threadedportion of the top and/or bottom member, such as the threaded portion1941 of the bottom member 1930 in FIG. 39. The lower screw portion 1913can comprise a pointed distal tip that allows the set screw 1912 toengage with a vertebral body. After rod members are received within thesystem 2000, the set screw 1912 can be rotated to thereby secure the rodmembers therein.

Advantageously, rotation of the single set screw 1912 provides a lockingmechanism for both of the rod members, thereby reducing the time neededto implant a dual rod construct within a body.

In some embodiments, the set screw 1912 can include a reverse single ordual outer diameter thread. If a surgeon desires to disassemble anassembled staple stabilization system by unscrewing the set screw 1912,the addition of the reverse thread can serve as a safety mechanism tolimit the complete removal of the set screw from the system within abody of the patient. In some embodiments, if a top portion of the threadis modified, then fully backed up, the set screw and top member willrotate simultaneously, without the need of additional drivers.

FIG. 36 illustrates a side view of a staple stabilization systemaccording to some embodiments of the present application. The staplestabilization system 2000 is assembled and ready to receive one or morerod members within the slots 1931 and 1932. As shown in FIG. 36, the topmember 1921 is inserted into the bottom member 1930, while the set screw2010 is received within an aperture formed through both of the members.

FIG. 37 is a top perspective view of a staple stabilization systemhaving rod members with a top member in an “open” position, while FIG.38 is a top perspective view of the staple stabilization system havingrod members with the top member in a “closed” position, according tosome embodiments of the present application. In the open configuration,the top member 1921 is oriented such that its sidewalls 1926 and 1927 donot overlap and/or obstruct the openings of the slots 1931 and 1932. Assuch, the staple stabilization system 2000 is capable of receiving bothof the rod members 1950 and 1952 therein in the open configuration. Insome embodiments, the staple stabilization system 2000 can also receivea single rod member therein. After the rod members 1950 and 1952 arereceived within the slots 1931 and 1932, the top member 1921 can berotated into a “closed” configuration (shown in FIG. 38) whereby each ofthe sidewalls 1926 and 1927 of the top member 1921 overlay a portion ofa rod member, thereby helping to secure both of the rod members withinthe system. In both the open and closed configurations, the staplestabilization system maintains a low profile, thereby helping to reducethe risk of injury to adjacent tissue in and around a surgical site.

FIG. 39 is a top perspective view of a bottom member of a staplestabilization system according to some embodiments of the presentapplication. From this view, the features of the bottom member 1930 areclearly shown. For example, FIG. 39 illustrates how the slots 1931 and1932 include textured or ridged features 1934 that serve as non-smoothsurfaces to securely hold the rod members. In addition, from thisfigure, a ramped surface 1937 is visible on the bottom member 1930. Thisramped surface 1937 advantageously helps to retain the top member 1921in a desired orientation within the bottom member 1930 during use.

FIG. 40 is a bottom view of a staple stabilization system according tosome embodiments of the present application. In this view, the staplestabilization system is in an “open” configuration, whereby the topmember 1921 is oriented to not obscure the slots and openings in thebottom member 1930.

FIG. 41 is a top perspective view of an alternative staplestabilizations system according to some embodiments of the presentapplication. Unlike the staple stabilization systems disclosed in FIGS.35-40, in which the set screw 1912 is “top-loaded” such that the threadsof the set screw mate with threads on the bottom member 1930, the staplestabilization system in FIG. 41 includes a set screw 1912 that is“bottom-loaded” such that the threads of the set screw mate with threadson the top member 1921. This system advantageously provides analternative means to secure the different components of the system in adesirable low-profile.

While certain features of the described implementations have beenillustrated as described herein, many modifications, substitutions,changes and equivalents will now occur to those skilled in the art. Itis, therefore, to be understood that the appended claims are intended tocover all such modifications and changes as fall within the scope of theembodiments.

What is claimed is:
 1. A surgical method comprising: providing astabilization system, wherein the stabilization system comprises: abottom member in the form of a plate having a top surface and a bottomsurface, the bottom member including a first opening extending from thetop surface to the bottom surface and a second opening extending fromthe top surface to the bottom surface; one or more protruding membersextending from the bottom surface of the bottom member; and a first bonescrew extending through the first opening and a second bone screwextending through the second opening, the first and second bone screwsconfigured to secure the system to a vertebral body.
 2. The method ofclaim 1, wherein the one or more protruding members are in the form of aprong configured to engage the vertebral body.
 3. The method of claim 2,wherein the prong has a pointed tip configured to engage the vertebralbody.
 4. The method of claim 1, wherein the system receives and securesone or more rod members therein.
 5. The method of claim 1, wherein theone or more rod members are received in the bottom member.
 6. The methodof claim 5, wherein the bottom member includes a slot configured toreceive one of the one or more rod members.
 7. The method of claim 1further comprising a set screw having a cylindrical body, and the setscrew secures the one or more rod members within the system.
 8. Themethod of claim 7, wherein the set screw is rotated to secure the one ormore rod members within the system.
 9. The method of claim 7 furthercomprising a top member positioned between the bottom member and the setscrew.
 10. A surgical method comprising: providing a stabilizationsystem, wherein the stabilization system comprises: a bottom memberhaving a top surface and a bottom surface, the bottom member including afirst opening extending from the top surface to the bottom surface and asecond opening extending from the top surface to the bottom surface; atop member engaged with the bottom member; one or more protrudingmembers extending from the bottom surface of the bottom member; a rodmember received in the bottom member; and a first bone screw extendingthrough the first opening and a second bone screw extending through thesecond opening, the first and second bone screws configured to securethe system to a vertebral body.
 11. The method of claim 10, wherein theone or more protruding members are in the form of a prong configured toengage the vertebral body.
 12. The method of claim 11, wherein the pronghas a pointed tip configured to engage the vertebral body.
 13. Themethod of claim 10, wherein the bottom member includes a slot configuredto receive the rod member.
 14. The method of claim 13 further comprisinga set screw having a cylindrical body, and the set screw secures the rodmember within the slot.
 15. The method of claim 14, wherein the setscrew is rotated to secure the rod member within the system.
 16. Themethod of claim 11, wherein the one or more protruding members include afirst prong extending from a first portion of the bottom surface of thebottom member and a second prong extending from a second portion of thebottom surface of the bottom member.
 17. A surgical method comprising:providing a stabilization system, wherein the stabilization systemcomprises: a bottom member having a top surface and a bottom surface,the bottom member including a first opening extending from the topsurface to the bottom surface and a second opening extending from thetop surface to the bottom surface; a top member engaged with the bottommember; one or more protruding members extending from the bottom surfaceof the bottom member; one or more rod members received in the bottommember; a first bone screw extending through the first opening and asecond bone screw extending through the second opening, the first andsecond bone screws configured to secure the system to a vertebral body;and a set screw having a cylindrical body, wherein the set screw isrotated to secure the one or more rod members within the bottom member.18. The method of claim 17, wherein the one or more protruding membersare in the form of a prong configured to engage the vertebral body. 19.The method of claim 18, wherein the prong has a pointed tip configuredto engage the vertebral body.
 20. The method of claim 18, wherein theone or more protruding members include a first prong extending from afirst portion of the bottom surface of the bottom member and a secondprong extending from a second portion of the bottom surface of thebottom member.